Email -
[email protected]
Role & responsibilities
:
1. IT Strategy & Leadership :
·
Develop and execute IT strategy
aligned with the company's business and regulatory goals.
· Lead
digital transformation initiatives
across departments (e.g., R&D;, manufacturing, QA, regulatory affairs).
· Assist manufacturing units in adopting
Industry 4.0
solutions (automation, AI).
· Strategizing and implementing technology that results in company growth.
· Effective MIS Generation with Minimum Effort and Duplication of Effort.
2. Infrastructure & Operations Management :
· Oversee
IT infrastructure
(network, servers, storage).
· Ensure
system availability
, scalability, and performance across locations.
· Manage
disaster recovery and business continuity plans
.
3. Regulatory Compliance & Validation :
· Ensure all IT systems comply with
FDA, EMA, MHRA
, and
21 CFR Part 11
regulations.
· Oversee
CSV (Computer System Validation)
processes and documentation.
· Implement
audit-ready systems
and support internal/external audits.
4. Data Governance & Security :
· Implement
cybersecurity protocols
to protect sensitive data.
· Ensure
data integrity
, privacy, and secure handling of patient/clinical trial information.
· Oversee
backup, archiving, and retention policies
in line with regulatory requirements.
5. Business Applications Management :
· Oversee deployment and support for:
·
ERP systems
(e.g., SAP, SAP HANA)
·
LIMS
(Laboratory Information Management Systems)
·
Caliber
(QMS Operation Systems)
· Ensure seamless integration between systems (e.g., between LIMS and SAP).
6. Team & Vendor Management :
· Lead and develop the
IT team
(support, infrastructure, developers, analysts).
· Manage
external vendors
, consultants, and service level agreements (SLAs).
· Budget planning and
cost optimization
for IT resources.
7.
Cross-Functional Collaboration
Preferred candidate profile
:
Expertise requires - SAP S4Hana, All Lab solution applica
📌 IT Head (Mumbai)
🏢 TECONICA SOFTWARES
📍 Mumbai